Butoxyethanol

What Is It?

Butoxyethanol is classified as an organic glycol etherAn organic compound that contains an oxygen atom bound to two hydrocarbon groups. An ether compound is often represented by R-O-R’.. In cosmetics and personal care products, it is primarily used in hair and nail products.

Why Is It Used?

Butoxyethanol is used primarily to dissolve other substances and to decrease the viscosity of liquid hair dyes and colors.

Scientific Facts

Butyoxyethanol, or 2-butoxyethanol, is an ether alcoholAlcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages. with a sweet odor. In addition to its use in cosmetic and personal care products, Butyoxyethanol is used in a number of industrial and household cleaning products.

Safety Information

The Food and Drug Administration (FDA) permits the use of ethylene glycol monobutyl ether (Butoxyethanol) as an indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage. as a component of adhesives, in sanitizing solutions, and as a secondary food additive not to exceed 1 ppm for washing or peeling fruits and vegetables. The safety of Butoxyethanol has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel.

The CIR Expert Panel reviewed the scientific data and concluded that Butoxyethanol is safe in hair and nail products at concentrations up to 10.0%. In 2002, as part of its regular re-review of cosmetic ingredients, the CIR Expert Panel considered available new data on Butoxyethanol and reaffirmed the above conclusion.

CIR Safety Review: At the expected maximum use concentration of 10%, there was no evidence of skin sensitization reactions to aqueous Butoxyethanol in a repeated insult patch test involving 201 subjects. The CIR Expert Panel concluded that 10% Butoxyethanol is a safe concentration for product formulations intended for rinse-off or leave-on application to human skin.

The CIR Expert Panel noted the severe ocular irritation potential of undiluted Butoxyethanol, but acknowledged that moderate to no corneal injuries were observed at aqueous concentrations of 15 and 5%, respectively, in test preparations. In consideration of these results, the ocular irritation potential of Butoxyethanol is not a concern at the concentrations expected in cosmetic product formulations.

FDA: Links to Code of Federal Regulations for Ethylene glycol monobutyl ether (Butoxyethanol)

The use of Butoxyethanol in cosmetic products marketed in Europe is permitted according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

Health Canada permits the use of this ingredient at concentrations equal to or less than 10% in hair dyes and nail products.
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…

More Scientific Information

Butyoxyethanol is used as a solventSubstances, usually liquids, that are used to dissolve other substances. as well as a viscosity-decreasing agent in hair dyes and colors to enhance the fluidity of these products. Viscosity decreasing agents are used in cosmetics to enhance the fluidity of products without a significant lowering of the concentration of the functional constituents.

Inorganic salts, organic salts, solvents, and a few selected substances have the ability to lower the viscosity of products. Their efficacy depends on their concentration and is highly specific for each type of product.

Resources

Agency for Toxic Substances and Disease Registry http://www.atsdr.cdc.gov/tfacts118.pdf

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/

The International Programme on Chemical Safety has developed a Concise International Chemical Assessment Document (CICAD) on 2-butoxyethanol. http://www.inchem.org/documents/cicads/cicads/cicad10.htm

Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has published a report on 2-butoxyethanol used in cleaning products. http://www.nicnas.gov.au/publications/car/pec/pec6/pec_6_full_report_pdf…